FDA 483 - ProSolus Inc - July 25, 2025

During an inspection conducted from July 21-25, 2025, the Food and Drug Administration issued a Form FDA 483 to a drug manufacturer located in Miami, FL. The observations highlighted significant deficiencies across the company's quality and production systems, impacting its operations for over-the-counter (OTC) and prescription (Rx) drug products. Key issues included a failure to follow established quality control procedures, specifically the omission of an Out-of-Specification investigation for an OTC drug product and the neglect of periodic supplier re-qualification, with many suppliers last reviewed several years prior. Furthermore, the inspection revealed a systemic failure to conduct annual product reviews for numerous batches of OTC drug products manufactured and distributed between 2020 and 2025. Critically, the firm lacked adequate written procedures and supporting data for production and process controls essential to assure the identity, strength, purity, and quality of its OTC drug products. These observations indicate non-adherence to the Federal Food, Drug, and Cosmetic Act and current Good Manufacturing Practices. The company is expected to promptly address these deficiencies to ensure full regulatory compliance in its manufacturing processes.